Medical device and IVD Sponsors have been patiently waiting for significant progress to be made within EUDAMED given the quickly approaching dates of application for MDR and IVDR (May 2020 and May 2021, respectively). At last, the system is taking shape and gaining momentum.
In this White Paper, provided is an overview of the latest developments regarding the European Union’s (EU) EUDAMED medical device database. Central to these updates is the release of the Actor Registration Module (December 2020) and associated documentation providing guidance to industry.
We invite you to access NAMSA’s White Paper to gain a better understanding of the recently released module and associated Frequently Asked Questions (FAQ) document, as well as the remaining five expected modules to be published in the coming months. Also provided is a discussion of the various roles and considerations critical to avoiding registration delays and maintaining continued market access, including:
- The EUDAMED System
- EU Economic Operators
- Non-EU Economic Operators
- Actor Roles
- Single Registration Number (SRN)
- Person Responsible for Regulatory Compliance (PRRC)
- Local Actor Administrator (LAA)
- Advantages of Early Registration
- Future Developments
Please fill out the form below to access this white paper.
We also invite you to learn more about NAMSA’s IVD Services by clicking here.